Volumetric Evaluation of Gingival Augmentation Around Dental Implants

NCT06057363 | Completed

• 1 other identifier: 20546-oss
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational prospective study is to objectively assess the dimensional (volume \& linear variance) and clinical changes of vestibular gingival soft tissues upon treatment with laser-aided pouch roll augmentation technique and implant placement over a 12-month follow-up. Twelve patients with 16 mild horizontal ridge deficiencies in different edentulous sites scheduled for implant placement were enrolled. Digital impressions were taken with an intra-oral laser scanner and software and analyzed before (day 0) and 12 months after laser-aided pouch roll augmentation surgery. The digital files were converted to STL format and superimposed to assess peri-implant volumetric and linear dimensional variations in selected regions of interest (ROI) by a 3D analysis software. Operator-assessed clinical periodontal parameters (probing depth PD, bleeding on probing BoP, plaque index PI) were recorded. Patient-reported outcome (pain, discomfort, treatment liking) and aesthetic result were evaluated by administration of appropriate questionnaires.

Conditions

Atrophy of Gingiva

Keywords

dental implants; roll flap; gingival augmentation; volume changes; linear dimensional changes; clinical periodontal parameters; patient-reported outcomes

Outcome Measures

Primary Outcomes (2)

• Objectively measurable volume changes of the vestibular gingiva

  Assessment of peri-implant volumetric variations (cubic mm) in selected regions of interest (ROI) of the vestibular gingiva by a 3D analysis software

  12 months

• Objectively measurable linear dimensional (LD) changes of the vestibular gingiva

  Assessment of peri-implant linear dimensional variations (mm) at 3 vertical points (1,3,5 mm form the free margin) in selected regions of interest (ROI) of the vestibular gingiva by a 3D analysis software

  12 months

Secondary Outcomes (7)

• Changes in periodontal probing depth PD (mm)

  12 months

• Changes in periodontal bleeding on probing BoP

  12 months

• Changes in periodontal plaque index PI

  12 months

• Subjective perception of discomfort and pain during surgery and the post-operative period

  7 days

• Analgesics taken

  7 days

Study Arms (1)

patients requiring vestibular soft tissue augmentation at implant sites

The present study was planned as prospective analysis with 12-month follow-up. It enrolled 12 partially edentulous patients (mean age 62; range 42-86) requiring vestibular soft tissue augmentation at implant sites in second-stage surgery because of mild horizontal ridge deficiency. As a whole, 16 implants were placed (8 single, 4 dual).

Other: volumetric evaluation of gingival augmentation around dental implants

Interventions

volumetric evaluation of gingival augmentation around dental implants OTHER

objective volumetric and clinical assesment of vestibular gingival soft tissues changes upon treatment with laser-aided pouch roll augmentation technique and implant placement over a 12-month follow-up

patients requiring vestibular soft tissue augmentation at implant sites

Eligibility Criteria

• Age: 42 Years - 86 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

12 partially edentulous patients (mean age 62; range 42-86; 9 males/5 females) requiring vestibular soft tissue augmentation at implant sites in second-stage surgery because of mild horizontal ridge deficiency were enrolled

You may qualify if:

• Age \> 18 years.
• Self-reported smoking habits \>10 cigarettes/day.
• Full-mouth plaque score and full-mouth bleeding score ≤15%, measured at four sites per tooth.
• Need for aesthetic and/or functional soft tissue augmentation in single or multiple implant sites at the upper and/or lower quadrants.

You may not qualify if:

• Diseases affecting connective tissue metabolism.
• Uncontrolled diabetes (glycated hemoglobin HbA1c \>7).
• Pregnant or lactating women.
• Untreated periodontal disease.
• Heavy gingival pigmentation (grade 3 Dummet Oral Pigmentation Index) requiring substantially different photoablative laser settings

Sponsors & Collaborators

• Odontostomatologic Laser Therapy Center, Florence, Italy: lead
• University of Florence: collaborator

Study Sites (1)

Odontostomatologic Laser Therapy Center

Florence, 50143, Italy

Location

Related Publications (15)

• Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available.

  PMID: 6950834 BACKGROUND

• Bassetti RG, Stahli A, Bassetti MA, Sculean A. Soft tissue augmentation around osseointegrated and uncovered dental implants: a systematic review. Clin Oral Investig. 2017 Jan;21(1):53-70. doi: 10.1007/s00784-016-2007-9. Epub 2016 Nov 21.

  PMID: 27873018 BACKGROUND

• El-Kholey KE. Efficacy and safety of a diode laser in second-stage implant surgery: a comparative study. Int J Oral Maxillofac Surg. 2014 May;43(5):633-8. doi: 10.1016/j.ijom.2013.10.003. Epub 2013 Nov 7.

  PMID: 24210453 BACKGROUND

• Fons-Badal C, Alonso Perez-Barquero J, Martinez-Martinez N, Faus-Lopez J, Fons-Font A, Agustin-Panadero R. A novel, fully digital approach to quantifying volume gain after soft tissue graft surgery. A pilot study. J Clin Periodontol. 2020 May;47(5):614-620. doi: 10.1111/jcpe.13235. Epub 2020 Mar 12.

  PMID: 31860133 BACKGROUND

• Fornaini C, Merigo E, Vescovi P, Bonanini M, Antonietti W, Leoci L, Lagori G, Meleti M. Different laser wavelengths comparison in the second-stage implant surgery: an ex vivo study. Lasers Med Sci. 2015 Aug;30(6):1631-9. doi: 10.1007/s10103-014-1623-3. Epub 2014 Jul 3.

  PMID: 24989333 BACKGROUND

• Giannelli M, Formigli L, Bani D. Comparative evaluation of photoablative efficacy of erbium: yttrium-aluminium-garnet and diode laser for the treatment of gingival hyperpigmentation. A randomized split-mouth clinical trial. J Periodontol. 2014 Apr;85(4):554-61. doi: 10.1902/jop.2013.130219. Epub 2013 Jul 4.

  PMID: 23826649 BACKGROUND

• Giannelli M, Formigli L, Lorenzini L, Bani D. Combined photoablative and photodynamic diode laser therapy as an adjunct to non-surgical periodontal treatment: a randomized split-mouth clinical trial. J Clin Periodontol. 2012 Oct;39(10):962-70. doi: 10.1111/j.1600-051X.2012.01925.x. Epub 2012 Jul 27.

  PMID: 22834932 BACKGROUND

• Gonzalez-Martin O, Veltri M, Moraguez O, Belser UC. Quantitative three-dimensional methodology to assess volumetric and profilometric outcome of subepithelial connective tissue grafting at pontic sites: a prospective pilot study. Int J Periodontics Restorative Dent. 2014 Sep-Oct;34(5):673-9. doi: 10.11607/prd.1808.

  PMID: 25171038 BACKGROUND

• Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.

  PMID: 26660000 BACKGROUND

• Park SH, Wang HL. Pouch roll technique for implant soft tissue augmentation: a variation of the modified roll technique. Int J Periodontics Restorative Dent. 2012 Jun;32(3):e116-21.

  PMID: 22408781 BACKGROUND

• Parvini P, Galarraga-Vinueza ME, Obreja K, Magini RS, Sader R, Schwarz F. Prospective study assessing three-dimensional changes of mucosal healing following soft tissue augmentation using free gingival grafts. J Periodontol. 2021 Mar;92(3):400-408. doi: 10.1002/JPER.19-0640. Epub 2020 Aug 21.

  PMID: 33448379 BACKGROUND

• Schmidt A, Klussmann L, Wostmann B, Schlenz MA. Accuracy of Digital and Conventional Full-Arch Impressions in Patients: An Update. J Clin Med. 2020 Mar 4;9(3):688. doi: 10.3390/jcm9030688.

  PMID: 32143433 BACKGROUND

• Tavelli L, Barootchi S, Majzoub J, Siqueira R, Mendonca G, Wang HL. Volumetric changes at implant sites: A systematic appraisal of traditional methods and optical scanning-based digital technologies. J Clin Periodontol. 2021 Feb;48(2):315-334. doi: 10.1111/jcpe.13401. Epub 2020 Nov 18.

  PMID: 33151586 BACKGROUND

• Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.

  PMID: 29498129 BACKGROUND

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.

  PMID: 25046131 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Marco Giannelli, MD

  Odontostomatologic Laser Therapy Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 28, 2023
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)